Comprehensive Medication Review Completion Rates and Disparities After Medicare Star Rating Measure.

Importance: Comprehensive medication reviews (CMRs) are offered to qualifying US Medicare beneficiaries annually to optimize medication regimens and therapeutic outcomes. In 2016, Medicare adopted CMR completion as a Star Rating quality measure to encourage the use of CMRs. Objective: To examine trends in CMR completion rates before and after 2016 and whether racial, ethnic, and socioeconomic disparities in CMR completion changed. Design, Setting, and Participants: This observational study using interrupted time-series analysis examined 2013 to 2020 annual cohorts of community-dwelling Medicare beneficiaries aged 66 years and older eligible for a CMR as determined by Part D plans and by objective minimum eligibility criteria. Data analysis was conducted from September 2022 to February 2024. Exposure: Adoption of CMR completion as a Star Rating quality measure in 2016. Main Outcome and Measures: CMR completion modeled via generalized estimating equations. Results: The study included a total of 561 950 eligible beneficiaries, with 253 561 in the 2013 to 2015 cohort (median [IQR] age, 75.8 [70.7-82.1] years; 90 778 male [35.8%]; 6795 Asian [2.7%]; 24 425 Black [9.6%]; 7674 Hispanic [3.0%]; 208 621 White [82.3%]) and 308 389 in the 2016 to 2020 cohort (median [IQR] age, 75.1 [70.4-80.9] years; 126 730 male [41.1%]; 8922 Asian [2.9%]; 27 915 Black [9.1%]; 7635 Hispanic [2.5%]; 252 781 White [82.0%]). The unadjusted CMR completion rate increased from 10.2% (7379 of 72 225 individuals) in 2013 to 15.6% (14 185 of 90 847 individuals) in 2015 and increased further to 35.8% (18 376 of 51 386 individuals) in 2020, in part because the population deemed by Part D plans to be MTM-eligible decreased by nearly half after 2015 (90 487 individuals in 2015 to 51 386 individuals in 2020). Among a simulated cohort based on Medicare minimum eligibility thresholds, the unadjusted CMR completion rate increased but to a lesser extent, from 4.4% in 2013 to 12.6% in 2020. Compared with White beneficiaries, Asian and Hispanic beneficiaries experienced greater increases in likelihood of CMR completion after 2016 but remained less likely to complete a CMR. Dual-Medicaid enrollees also experienced greater increases in likelihood of CMR completion as compared with those without either designation, but still remained less likely to complete CMR. Conclusion and Relevance: This study found that adoption of CMR completion as a Star Rating quality measure was associated with higher CMR completion rates. The increase in CMR completion rates was achieved partly because Part D plans used stricter eligibility criteria to define eligible patients. Reductions in disparities for eligible Asian, Hispanic, and dual-Medicaid enrollees were seen, but not eliminated. These findings suggest that quality measures can inform plan behavior and could be used to help address disparities.

Central nervous system medication use around hospitalization.

BACKGROUND: Central nervous system (CNS) medication use is common among older adults, yet the impact of hospitalizations on use remains unclear. This study details CNS medication use, discontinuations, and user profiles during hospitalization periods. METHODS: Retrospective cohort study using electronic health records on patients ≥65 years, from three hospitals (2018-2020), and prescribed a CNS medication around hospitalization (90 days prior to 90 days after). Latent class transitions analysis (LCTA) examined profiles of CNS medication class users across four time points (90 days prior, admission, discharge, 90 days after hospitalization). RESULTS: Among 4666 patients (mean age 74.3 ± 9.3 years; 63% female; 70% White; mean length of stay 4.6 ± 5.6 days (median 3.0 [2.0, 6.0]), the most commonly prescribed CNS medications were antidepressants (56%) and opioids (49%). Overall, 74% (n = 3446) of patients were persistent users of a CNS medication across all four time points; 7% (n = 388) had discontinuations during hospitalization, but of these, 64% (216/388) had new starts or restarts within 90 days after hospitalization. LCTA identified three profile groups: (1) low CNS medication users, 54%-60% of patients; (2) mental health medication users, 30%-36%; and (3) acute/chronic pain medication users, 9%-10%. Probability of staying in same group across the four time points was high (0.88-1.00). Transitioning to the low CNS medication use group was highest from admission to discharge (probability of 9% for pain medication users, 5% for mental health medication users). Female gender increased (OR 2.4, 95% CI 1.3-4.3), while chronic kidney disease lowered (OR 0.5, 0.2-0.9) the odds of transitioning to the low CNS medication use profile between admission and discharge. CONCLUSIONS: CNS medication use stays consistent around hospitalization, with discontinuation more likely between admission and discharge, especially among pain medication users. Further research on patient outcomes is needed to understand the benefits and harms of hospital deprescribing, particularly for medications requiring gradual tapering.

Family Involvement in the Care of Hospitalized Older Adults: Protocol for a Qualitative Evidence Synthesis.

BACKGROUND: Older adults are frequently hospitalized. Family involvement during these hospitalizations is incompletely characterized in the literature. OBJECTIVE: This study aimed to better understand how families are involved in the care of hospitalized older adults and develop a conceptual model describing the phenomenon of family involvement in the care of hospitalized older adults. METHODS: We describe the protocol of a qualitative evidence synthesis (QES), a systematic review of qualitative studies. We chose to focus on qualitative studies given the complexity and multifaceted nature of family involvement in care, a type of topic best understood through qualitative inquiry. The protocol describes our process of developing a research question and eligibility criteria for inclusion in our QES based on the SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, and Research type) tool. It describes the development of our search strategy, which was used to search MEDLINE (via Ovid), Embase (via Elsevier), PsycINFO (via Ovid), and CINAHL Complete (via EBSCO). Title and abstract screening and full-text screening will occur sequentially. Purposive sampling may be used depending on the volume of studies identified as eligible for inclusion during our screening process. Descriptive data regarding included individual studies will be extracted and summarized in tables. The results from included studies will be synthesized using qualitative methods and used to develop a conceptual model. The conceptual model will be presented to community members via engagement panels for further refinement. RESULTS: As of September 2023, we have assembled a multidisciplinary team including physicians, nurses, health services researchers, a librarian, a social worker, and a health economist. We have finalized our search strategy and executed the search, yielding 8862 total citations. We are currently screening titles and abstracts and anticipate that full-text screening, data extraction, quality appraisal, and synthesis will be completed by summer of 2024. Conceptual model development will then take place with community engagement panels. We anticipate submitting our manuscript for publication in the fall of 2024. CONCLUSIONS: This paper describes the protocol for a QES of family involvement in the care of hospitalized older adults. We will use identified themes to create a conceptual model to inform further intervention development and policy change. TRIAL REGISTRATION: PROSPERO 465617; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023465617. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53255.

Allostatic Load, Morbidity, and Mortality Among Older Adults: A Multi-Wave Analysis From the National Health and Aging Trends Study.

Although allostatic load (AL) is a key concept to reflect physiologic wear and tear from stress, older adults are underrepresented in AL-related research, especially the oldest old (≥80). Further, attenuative factors are often unaccounted for. This longitudinal analysis using data from National Health and Aging Trends Study investigated relationships of AL in 2017 and multi-wave (1) comorbidity accumulation using multilevel Poisson modeling and (2) mortality risk using survival analysis. By year five (2022), each incremental AL increase that older adults (n = 3614) experienced was associated with a 47% increase in comorbidity (p < .001), and a 33% increased mortality risk (p < .001). This research supports a shift to a more proactive, health promotion/risk mitigation paradigm through informing intervention research targeting AL, which is currently scarce. Identifying potentially modifiable and key driving factors influencing the relationship between AL and health among older adults is an important next step to inform intervention design.

Evaluation of strategies to support implementation of a hospital walking program: protocol for a type III effectiveness-implementation hybrid trial.

BACKGROUND: STRIDE is a supervised walking program designed to address the negative consequences of immobility during hospitalization for older adults. In an 8-hospital stepped wedge randomized controlled trial, STRIDE was associated with reduced odds of hospital discharge to skilled nursing facility. STRIDE has the potential to become a system-wide approach to address hospital-associated disability in Veteran's Affairs; however, critical questions remain about how best to scale and sustain the program. The overall study goal is to compare the impact of two strategies on STRIDE program penetration (primary), fidelity, and adoption implementation outcomes. METHODS: Replicating Effective Programs will be used as a framework underlying all implementation support activities. In a parallel, cluster randomized trial, we will use stratified blocked randomization to assign hospitals (n = 32) to either foundational support, comprised of standard, low-touch activities, or enhanced support, which includes the addition of tailored, high-touch activities if hospitals do not meet STRIDE program benchmarks at 6 and 8 months following start date. All hospitals begin with foundational support for 6 months until randomization occurs. The primary outcome is implementation penetration defined as the proportion of eligible hospitalizations with ≥ 1 STRIDE walks at 10 months. Secondary outcomes are fidelity and adoption with all implementation outcomes additionally examined at 13 and 16 months. Fidelity will be assessed for STRIDE hospitalizations as the percentage of eligible hospital days with "full dose" of the program, defined as two or more documented walks or one walk for more than 5 min. Program adoption is a binary outcome defined as ≥ 5 patients with a STRIDE walk or not. Analyses will also include patient-level effectiveness outcomes (e.g., discharge to nursing home, length of stay) and staffing and labor costs. We will employ a convergent mixed-methods approach to explore and understand pre-implementation contextual factors related to differences in hospital-level adoption. DISCUSSION: Our study results will dually inform best practices for promoting successful implementation of an evidence-based hospital-based walking program. This information may support other programs by advancing our understanding of how to apply and scale-up national implementation strategies. TRIAL REGISTRATION: This study was registered on June 1, 2021, at ClinicalTrials.gov (identifier NCT04868656 ).

Emergency Department-to-Community Transitions of Care: Best Practices for the Older Adult Population.

This article describes emergency department (ED)-to-community care transitions for older adults and associated challenges, measurement, proven efficacious and effective interventions, and policy considerations. Older adults experiencing social isolation and impairments in functional status or cognition represent unique populations that are particularly at risk during ED-to-community transitions of care and may benefit from targeted intervention implementation. Future efforts should target optimizing screening techniques to identify those at risk, developing and validating patient-centered outcome measures, and using policy and reimbursement levers to include transitional care management services for older adults within the ED setting.

Group physical therapy for knee osteoarthritis: protocol for a hybrid type III effectiveness-implementation trial.

BACKGROUND: Knee osteoarthritis (OA) is a leading cause of chronic pain and disability and one of the most common conditions treated in outpatient physical therapy (PT). Because of the high and growing prevalence of knee OA, there is a need for efficient approaches for delivering exercise-based PT to patients with knee OA. A prior randomized controlled trial (RCT) showed that a 6-session Group Physical Therapy Program for Knee OA (Group PT) yields equivalent or greater improvements in pain and functional outcomes compared with traditional individual PT, while requiring fewer clinician hours per patient to deliver. This manuscript describes the protocol for a hybrid type III effectiveness-implementation trial comparing two implementation packages to support delivery of Group PT. METHODS: In this 12-month embedded trial, a minimum of 16 Veterans Affairs Medical Centers (VAMCs) will be randomized to receive one of two implementation support packages for their Group PT programs: a standard, low-touch support based on Replicating Effective Programs (REP) versus enhanced REP (enREP), which adds tailored, high-touch support if sites do not meet Group PT adoption and sustainment benchmarks at 6 and 9 months following launch. Implementation outcomes, including penetration (primary), adoption, and fidelity, will be assessed at 6 and 12 months (primary assessment time point). Additional analyses will include patient-level effectiveness outcomes (pain, function, satisfaction) and staffing and labor costs. A robust qualitative evaluation of site implementation context and experience, as well as site-led adaptations to the Group PT program, will be conducted. DISCUSSION: To our knowledge, this study is the first to evaluate the impact of tailored, high-touch implementation support on implementation outcomes when compared to standardized, low-touch support for delivering a PT-based intervention. The Group PT program has strong potential to become a standard offering for PT, improving function and pain-related outcomes for patients with knee OA. Results will provide information regarding the effectiveness and value of this implementation approach and a deeper understanding of how healthcare systems can support wide-scale adoption of Group PT. TRIAL REGISTRATION: This study was registered on March 7, 2022 at ClinicalTrials.gov (identifier NCT05282927 ).

Optimizing remote access to urinary incontinence treatments for women veterans (PRACTICAL): Study protocol for a pragmatic clinical trial comparing two virtual care options.

OBJECTIVES: In this pragmatic clinical trial, the primary objective is to increase access to behavioral treatment of urinary incontinence (UI) for women Veterans by comparing the effectiveness of two virtual care delivery modalities. METHODS: Veterans Affairs (VA) clinical sites in AL, GA, NC will virtually randomize 286 women Veterans with UI (ie, stress, urge, or mixed). We will compare the effectiveness of our mHealth UI application (MyHealtheBladder) to a single VA Video Connect (VVC) session delivered by trained UI providers. Women without improvement after 8 weeks will receive an optimization VVC visit using a sequential, multiple assignment, randomized trial (SMART) design. The primary outcome is UI symptom improvement at 12-weeks with or without optimization; secondary outcomes include improvements in lower urinary tract symptoms, adherence, retention rates, perceptions of improvement, and visit-related miles saved. Sample size needed to identify a 2.5-point change (range 0-21) in the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) from baseline to 12-weeks post-randomization is 200 participants. Allowing for an attrition rate of 25%, 286 participants are required. KEY RESULTS: Study team initiated remote recruitment on April 2020. Recruitment is on target with a 75% retention rate. We expect completion in fall of 2023 (clinicaltrials.govNCT04237753). DISCUSSION/CONCLUSION: Engaging women Veterans with virtual modalities for initial UI treatment may increase access to UI care while also improving symptoms. After assessing efficacy, adherence, and retention, the next step is to implement the most effective option for remote delivery of evidence-based behavioral UI treatment for women Veterans. TRIAL REGISTRATION: ClinicalTrials.gov number NCT04237753.

Effects of Implementation of a Supervised Walking Program in Veterans Affairs Hospitals : A Stepped-Wedge, Cluster Randomized Trial.

BACKGROUND: In trials, hospital walking programs have been shown to improve functional ability after discharge, but little evidence exists about their effectiveness under routine practice conditions. OBJECTIVE: To evaluate the effect of implementation of a supervised walking program known as STRIDE (AssiSTed EaRly MobIlity for HospitalizeD VEterans) on discharge to a skilled-nursing facility (SNF), length of stay (LOS), and inpatient falls. DESIGN: Stepped-wedge, cluster randomized trial. (ClinicalTrials.gov: NCT03300336). SETTING: 8 Veterans Affairs hospitals from 20 August 2017 to 19 August 2019. PATIENTS: Analyses included hospitalizations involving patients aged 60 years or older who were community dwelling and admitted for 2 or more days to a participating medicine ward. INTERVENTION: Hospitals were randomly assigned in 2 stratified blocks to a launch date for STRIDE. All hospitals received implementation support according to the Replicating Effective Programs framework. MEASUREMENTS: The prespecified primary outcomes were discharge to a SNF and hospital LOS, and having 1 or more inpatient falls was exploratory. Generalized linear mixed models were fit to account for clustering of patients within hospitals and included patient-level covariates. RESULTS: Patients in pre-STRIDE time periods (n = 6722) were similar to post-STRIDE time periods (n = 6141). The proportion of patients with any documented walk during a potentially eligible hospitalization ranged from 0.6% to 22.7% per hospital. The estimated rates of discharge to a SNF were 13% pre-STRIDE and 8% post-STRIDE. In adjusted models, odds of discharge to a SNF were lower among eligible patients hospitalized in post-STRIDE time periods (odds ratio [OR], 0.6 [95% CI, 0.5 to 0.8]) compared with pre-STRIDE. Findings were robust to sensitivity analyses. There were no differences in LOS (rate ratio, 1.0 [CI, 0.9 to 1.1]) or having an inpatient fall (OR, 0.8 [CI, 0.5 to 1.1]). LIMITATION: Direct program reach was low. CONCLUSION: Although the reach was limited and variable, hospitalizations occurring during the STRIDE hospital walking program implementation period had lower odds of discharge to a SNF, with no change in hospital LOS or inpatient falls. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs Quality Enhancement Research Initiative (Optimizing Function and Independence QUERI).

Patient experiences of a care transition intervention for Veterans to reduce emergency department visits.

OBJECTIVES: Care transition interventions (CTIs) are used to improve outcomes after an emergency department (ED) visit. A recent randomized controlled trial of a Veterans Health Administration (VHA) CTI titled Discharge Information and Support for Patients receiving Outpatient care in the ED (DISPO ED) demonstrated no difference in repeat ED visits. However, changes in health care utilization are not the only measures of a CTI worth evaluation, and there is interest in using patient-centered outcomes to assess CTIs as well. To inform future CTI design and outcome measure selection, the study aims were to understand how patients experienced the CTI and what elements they valued. METHODS: This was a qualitative study of participants randomized to the intervention arm of the DISPO ED trial using semistructured interviews. The interview guide included questions about clinical health and other issues addressed by the study nurse, the most and least helpful aspects of the intervention, and impacts of the intervention on their perceptions of self-management. Interviews were analyzed using directed content analysis. RESULTS: Our sample comprised 24 participants, with average age of 61 years, 58% male, and 50% Black or African American. We identified six major themes related to (1) experiences during the intervention and (2) elements they valued. Patients reported clinical health coaching recommendations covering a wide range of topics as well as care coordination actions such as appointment scheduling. Valuable elements of the intervention highlighted personal characteristics of the study nurse that promoted a sense of interpersonal connection and empathy in their interactions. CONCLUSIONS: Intervention users described assistance with care coordination as well as clinical concerns. We identified aspects that were highly valued by the participants, such as interpersonal support and empathy from the interventionist. These findings suggest the need for more comprehensive nonutilization outcome measures for CTIs to capture the patient's perspective.

Racial inequality in functional trajectories between Black and White U.S. veterans.

BACKGROUND: Racial inequality in functional trajectories has been well documented in the U.S. civilian population but has not been explored among Veterans. Our objectives were to: (1) assess how functional trajectories differed for Black and White Veterans aged ≥50 and (2) explore how socioeconomic, psychosocial, and health-related factors altered the relationship between race and function. METHODS: We conducted a prospective, longitudinal analysis using the 2006-2016 Health and Retirement Study. The study cohort included 3700 Veterans who self-identified as Black or White, responded to baseline psychosocial questionnaires, and were community-dwelling on first observation. We used stepwise and stratified linear mixed effects models of biannually assessed functional limitations. The outcome measure was as a count of functional limitations. Race was measured as respondent self-identification as Black or White. Demographic measures included gender and age. Socioeconomic resources included partnership status, education, income, and wealth. Psychosocial stressors included exposure to day-to-day and major discrimination, traumatic life events, stressful life events, and financial strain. Health measures included chronic and mental health diagnoses, smoking, rurality, and use of Veterans Affairs services. RESULTS: Black Veterans developed functional limitations at earlier ages and experienced faster functional decline than White Veterans between the ages of 50 and 70, with convergence occurring at age 85. Once we accounted for economic resources and psychosocial stressors in multivariable analyses, the association between race and the number of functional limitations was no longer statistically significant. Lower wealth, greater financial strain, and traumatic life events were significantly associated with functional decline. CONCLUSIONS: Health systems should consider how to track Veterans' function earlier in the life course to ensure that Black Veterans are able to get timely access to services that may slow premature functional decline. Providers may benefit from training about the role of economic resources and psychosocial stressors in physical health outcomes.

Mandated Caregiver Training in the Veterans Health Administration: Caregiver Inquiry Informs National Dissemination.

BACKGROUND AND OBJECTIVES: A minority of family caregivers receive training, with implications for their own and their recipient's outcomes. Federal policy has supported the implementation and expansion of caregiver training and support. The Department of Veterans Affairs (VA) has developed a national Caregiver Support Program and collaborated with VA health services researchers to explore caregivers' acceptance of an evidence-based training program in preparation for system-wide dissemination. RESEARCH DESIGN AND METHODS: This approach entailed a convergent mixed-methods design, which involved separate analyses of quantitative and qualitative data. Survey questions based on the Kirkpatrick model for training evaluation measured caregivers' reaction and learning, and interview questions elicited caregivers' reports about the value of the program for them. RESULTS: Most caregivers reported satisfaction with the training when responding to survey questions, although qualitative interviews revealed caveats suggesting need to hone the best timing and specific group of caregivers for maximal benefit. DISCUSSION AND IMPLICATIONS: Our findings indicate that understanding program-user fit may be particularly critical when implementing training for caregivers as they come to the program at different points along their caregiving journey, needing differing types and intensities of support. While a general program may appeal to policymakers aiming to scale caregiver training within a large, heterogeneous system, there may be shortcomings in terms of end-user acceptance and subsequent downstream outcomes such as reach and ultimately program effectiveness. Good, iterative communication flow between program developers and policymakers facilitates this understanding and, in turn, decisions about scaling.

Social Risk Factors Are Associated With Disability Prevalence - Results From 17 States in the 2017 Behavioral Risk Factor Surveillance System.

PURPOSE: Determine the association between incremental increases in the number of social risk factors and the prevalence of any disability and disability type. DESIGN: The cross-sectional analysis was conducted using 2017 Behavioral Risk Factor Surveillance System data from states whose surveys included items about social risk factors. SETTING: Respondents from 17 US states. SUBJECTS: Respondents included 136 432 adults. MEASURES: Dichotomized social risk factors included food, housing, and financial insecurity, unsafe neighborhood, and healthcare access hardship. ANALYSIS: Weighted χ2 and logistic regression analyses adjusted for demographic characteristics, measures of socioeconomic position, and comorbid health conditions were used to examine differences in the prevalence of disability by social risk factor and via a social risk index created by summing the social risk factors. RESULTS: Compared to those reporting 0 social risk factors, respondents reporting ≥4 had more than thrice the odds of reporting a cognition ((adjusted odds ratio [AOR]=3.37; 95%CI [2.75-4.13]), independent living (AOR=3.24 [2.52-4.15]), self-care (AOR=3.33 [2.55-4.34]), or any disability (AOR=3.90 [3.24-4.70]); more than twice the odds of reporting a vision (AOR=2.61 [1.93-3.52]) or mobility (AOR=2.72 [2.16-3.41]) disability; and more than 1.5 times the odds of reporting a hearing disability (AOR=1.59 [1.22-2.07]). CONCLUSIONS: Incremental increases in the number of social risk factors were independently associated with higher odds of disability. Intervention efforts should address the social context of US adults with disabilities to improve health outcomes.

Development of a Home-Based Stress Management Toolkit for Dementia Caring Dyads: Protocol for a Pilot Intervention Development and Feasibility Study.

BACKGROUND: People living with dementia (PLWD) and their care partners (dementia caring dyads) are at a heightened risk of experiencing stress-related symptoms and conditions. Yet, many dyadic stress management interventions have had limited uptake by health care systems and in the community. An intervention that combines simple, safe, easy-to-use, nonpharmacologic tools (eg, animatronic social pets, weighted blankets and garments, aromatherapy and bright light therapy devices, acupressure, and massage tools) that can be used in the home may be a promising approach to promote stress management among dementia caring dyads. OBJECTIVE: The proposed study aims to develop and user test a dyadic toolkit intervention composed of simple, tangible stress management tools for community-dwelling PLWD and their care partners. This study will also explore the feasibility of collecting several stress-related outcome measures to inform measurement selection for future studies. METHODS: A human-centered design (HCD) approach will be used to increase the likelihood of developing an intervention that will be translatable to real-world settings. This study consists of 2 phases. The first phase will address the discover, define, and design stages of HCD using qualitative focus groups with dementia caring dyads (N=12-16 dyads). Dyadic focus groups (3-4 groups anticipated) will be convened to understand participants' stress experiences and to co-design a stress management toolkit prototype. Rapid qualitative analysis will be used to analyze focus group data. In phase 2, the toolkit prototype will be user tested for 2 weeks in a new sample to address the validation step of HCD. A within-subjects (n=10 dyads), pre-post design will be used with measures of usability (frequency of toolkit use), feasibility (enrollment and withdrawal rates, adverse events/injuries), and acceptability (satisfaction, benefit) collected via questionnaires (at the end of weeks 1 and 2 of user testing) and focus groups (n=3-4 dyads/group at the end of week 2). The feasibility of collecting participant-reported, stress-related outcomes (neuropsychiatric symptoms of dementia, caregiver stress, dyadic relationship strain) and salivary cortisol as a physiologic measure of stress will be assessed at baseline and after user testing. RESULTS: This study will yield a working prototype of a stress management toolkit for dementia caring dyads, as well as preliminary data to support the feasibility and acceptability of the intervention. User testing will elucidate areas to refine the prototype and provide data to inform preliminary testing of the intervention. As of September 2022, this study has received institutional ethics board approval with phase 1 recruitment anticipated to begin January 2023. CONCLUSIONS: Few interventions have focused on combining simple, safe, low burden tools to promote stress management among community-dwelling dementia caring dyads. By involving families and exploring feasibility and acceptability at the onset of development, this intervention will have greater potential to be implemented and sustained in the future. TRIAL REGISTRATION: ClinicalTrials.gov NCT05465551; https://clinicaltrials.gov/ct2/show/NCT05465551. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/43098.

A pilot study combining noninvasive spinal neuromodulation and activity-based neurorehabilitation therapy in children with cerebral palsy.

Cerebral Palsy (CP) is the most common pediatric motor disability with multiple symptoms and etiologies. CP is exhibited through sensorimotor delays, impaired posture resulting in limited activities and participation. Our recently concluded, single arm, unblinded, pilot study (NCT04882592) explored whether an intervention combining non-invasive spinal neuromodulation during an activity-based neurorehabilitation therapy (ABNT) can improve voluntary sensory-motor function captured via the Gross Motor Function Measure (GMFM-88) scores (primary outcome). Sixteen children diagnosed with CP with Gross Motor Function Classification Scale levels I-V were recruited and received the same intervention (2x/week for 8 weeks) to correct the dysfunctional connectivity between supraspinal and spinal networks using the normally developed proprioception. We demonstrate that the intervention was associated with clinically and statistically significant improvement in GMFM-88 scores in all children, thus meeting the prespecified primary endpoint. However, the improvement with ABNT alone needs further exploration. No serious adverse events were observed (safety endpoint).

COVID-19 vaccination intention and activation among health care system employees: A mixed methods study.

BACKGROUND: Achieving high COVID-19 vaccination rates among employees is necessary to prevent outbreaks in health care settings. The goal of the study was to produce actionable and timely evidence about factors underlying the intention and decisions to obtain the COVID-19 vaccine by employees. METHODS: The study was conducted from December 2020 - May 2021 with employees from a VA health care system in Southeastern US. The study used a convergent mixed methods design comprising two main activities: a cross-sectional survey conducted prior to COVID-19 vaccine distribution, and semi-structured interviews conducted 4-6 months after vaccine distribution. Data were collected about participant characteristics, vaccination intention prior to distribution, vaccination decision post-distribution, determinants of vaccination intention and decision, activating factors, sources of information and intervention needs. Data from the survey and interviews were analyzed separately and integrated narratively in the discussion. RESULTS: Prior to vaccine distribution, 77% of employees wanted to be vaccinated. Post vaccine distribution, we identified 5 distinct decision-making groups: 1) vaccine believers who actively sought vaccination and included those sometimes described as "immunization advocates", 2) go along to get along (GATGA) individuals who got vaccinated but did not actively seek it, 3) cautious acceptors who got the COVID-19 vaccine after some delay, 4) fence sitters who remained uncertain about getting vaccinated, and 5) vaccine refusers who actively rejected the COVID-19 vaccine. Participants identifying with Black or multiple races were more likely to express hesitancy in their vaccination intention. CONCLUSION: The findings of our study highlight distinct decision-making profiles associated with COVID-19 vaccination among employees of a VA health care system, and provide tailored recommendations to reduce vaccine hesitancy in this population.

Adapting to CONNECT: modifying a nursing home-based team-building intervention to improve hospital care team interactions, functioning, and implementation readiness.

BACKGROUND: Clinical interventions often need to be adapted from their original design when they are applied to new settings. There is a growing literature describing frameworks and approaches to deploying and documenting adaptations of evidence-based practices in healthcare. Still, intervention modifications are often limited in detail and justification, which may prevent rigorous evaluation of interventions and intervention adaptation effectiveness in new contexts. We describe our approach in a case study, combining two complementary intervention adaptation frameworks to modify CONNECT for Quality, a provider-facing team building and communication intervention designed to facilitate implementation of a new clinical program. METHODS: This process of intervention adaptation involved the use of the Planned Adaptation Framework and the Framework for Reporting Adaptations and Modifications, for systematically identifying key drivers, core and non-core components of interventions for documenting planned and unplanned changes to intervention design. RESULTS: The CONNECT intervention's original context and setting is first described and then compared with its new application. This lays the groundwork for the intentional modifications to intervention design, which are developed before intervention delivery to participating providers. The unpredictable nature of implementation in real-world practice required unplanned adaptations, which were also considered and documented. Attendance and participation rates were examined and qualitative assessment of reported participant experience supported the feasibility and acceptability of adaptations of the original CONNECT intervention in a new clinical context. CONCLUSION: This approach may serve as a useful guide for intervention implementation efforts applied in diverse clinical contexts and subsequent evaluations of intervention effectiveness. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov ( NCT03300336 ) on September 28, 2017.